Senior Clinical Study Manager

2 months ago

Elstree, United Kingdom Bio Products Laboratory Limited Full time

Bio Products Laboratory (BPL), part of Kedrion Biopharma, is offering a new and exciting opportunity for a Senior Clinical Study Manager to join the Global Clinical Research & Operations (GCR&O) department.

This role involves overseeing the entire process from protocol concept to final study report for regional or global clinical trials, including phases I to IV and non-interventional data collections. Your responsibilities will include ensuring compliance with regulations and Kedrion's policies, meeting timelines and budget requirements, and maintaining high standards of patient safety and data quality.

This is a fully hybrid role however you but must be able to attend the site in Elstree, Hertfordshire, as required.

Depending on the project needs, you will be required to travel overseas in Europe and the US once to twice a year.

Duties & Responsibilities:

  • Responsible for ensuring that all activities are completed for assigned clinical trials to agreed timelines, budgets and data quality standards. Activities include but are not limited to the following:
  • Feasibility/Recruitment - Identification and selection of investigators willing to participate in clinical trials and managing study recruitment with respect to timelines and budget. Prepare and review study recruitment and retention materials, in conjunction with any partner CRO project manager.
  • Delivery of Clinical Trial – Includes set-up, maintenance and close-out procedures. Ensuring prompt identification and resolution upon any patient or trial related problems to satisfactory conclusion. Overall management of clinical trial with respect to patient safety, objectives, timelines and budget. This includes:
  • Development, review and finalization of study-specific plans and forms, including case report forms and statistical analysis plans
  • Ensure correct reporting of safety events
  • Monitoring/co-monitoring at study sites to standards required by Kedrion
  • Ensures prompt, quality communications with CROs/sites regarding protocol clarification and procedural queries
  • Ongoing data review and assisting with site issue resolution
  • CRO and Vendor Management – liaise with Procurement and GCR&O colleagues in request for proposal and selection of suppliers; manage and oversee setup, study delivery and close-out activities, while maintaining effective external partnerships. Ensure delegated responsibilities are being managed appropriately and according to contract. Perform sponsor oversight visits to sites and vendors.
  • Budget Management – develop and manage overall life of study budget, including forecasting, setup and approval, phasing and invoice reconciliation. Maximize cost efficiencies and escalate any over/under spend as required. Identify out of scope work in stream, and manage any change order required for new scope or out of scope activity.
  • Risk Management Strategies – initiate and develop study or site risk and action plans; plan for periodic study risk review and propose risk mitigation strategies.
  • Quality Assurance and Audits – ensure sites and vendors are conducting the trial in compliance with appropriate regulations. Ensure any findings and observations are addressed to resolution. May include preparation for and participation in regulatory inspections of selected clinical trials.
  • Meeting Management - organize meetings, agendas and take minutes as required. Prepare and present at vendor kick-off meetings, investigator meetings, within Kedrion and at symposia and conferences.
  • In conjunction with other functional teams and members of the GCR&O Department,
  • Prepare/review and approve clinical trial protocols, subject information leaflets/consent forms, Investigator Brochures, annual (safety) reports, clinical study reports and other trial documentation, to standards required by Kedrion.
  • Co-ordinate team review of trial documentation to meet required timelines.
  • Co-ordinate team review of clinical sections of regulatory licence applications, paediatric investigation/study plans, and regulatory briefing books for assigned clinical trials.
  • Maintain professional knowledge of Good Clinical Practice and related issues, including the EU Regulation, UK Statutory Instruments, US CFRs and other global regulations. Acquire and maintain a high level of knowledge of the product and related areas of assigned clinical trials, by reading relevant literature and attending courses/seminars.
  • Interacts internally with Global Clinical Research and Operations, Regulatory Affairs, Pharmacovigilance, Research and Development, and Medical Affairs team members
  • External interactions may include CRO study personnel, and investigator site staff
  • Supports the Clinical Research Leader in development of Key Opinion Leader relationships; organization of advisory boards and other scientific engagement activities; set up Data Safety Monitoring Board, if applicable

Skills & experience to help you within the role –

We are currently seeking a candidate who:

  • has a science degree or equivalent.
  • has relevant work experience within the clinical research environment within the Pharmaceutical or allied Industry.
  • is skilled in problem-solving, independent decision-making, and possesses strong communication abilities.
  • can excel in analysing complex data, multitasking, and working effectively under pressure while paying attention to detail.
  • has the ability to engage with senior personnel and healthcare professionals, along with a good understanding of Good Clinical Practice and regulatory requirements.
  • has a flexible approach to duties.

In return we offer -

We're looking for highly motivated and experienced people to drive the business forward. In return you'll be supported in developing your skills with ongoing training and career opportunities.

  • Competitive salary
  • Bonus
  • 25 days holiday
  • Pension
  • Life insurance
  • Private health insurance
  • On-site parking
  • Employee assistance programme
  • My Healthy Advantage phone app
  • Virtual GP
  • Cycle to work scheme

We are based in Elstree, just north of London, on a secure campus surrounded by natural beauty, greenery, lakes, and wildlife.

We employ just over 1000 colleagues who are involved in the full operation of a pharmaceutical company, involving everything from the Research & Development of new products, manufacturing our medicines, Engineering support of existing and new equipment, logistics and planning, and many more in between.

We take immense pride in the value and impact our therapies have and we work collaboratively together to achieve the demands of our patients.

Please apply today for immediate consideration.

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